Clinical Research
The results from 10 years of research were proven through 3 clinical trials.
In clinical trials conducted at the KRISS (Korea Research Institute of Standards and Science) and Kyunghee University Hospital in 2019 and 2020, the effectiveness of treatment was demonstrated through analysis on EEG (electroencephalogram), ECG (electrocardiogram), melatonin (hormone) and Insomnia Severity Index (ISI).
1st Clinical Trial: Proving Stress Reduction
KRISS (Korea Research Institute of Standards and Science)
In clinical trials conducted at the KRISS in South Korea in 2019, we demonstrated the parasympathetic activation effects of the ANS (autonomic nervous system) by analyzing ECG (Electrocardiogram).
Scientific Evidence
The VNS technology applied to amofit S was developed based on thousands of peer-reviewed papers, and its effectiveness was proven in the actual clinical trials. In a placebo-controlled study conducted at the KRISS, amofit S increased activities of the parasympathetic nervous system by up to 187%.
Conclusion
The result of analysis of ECG to evaluate the stress relaxation effects of AMO+ products are as follows:
- Scientific:
There were significant changes in HF ratio on ECG after use of AMO+ for a short term (2 hours). It is thought that the parasympathetic nervous system is activated by wearing the product in the experiment. It is considered that AMO+ induces relaxation and sleep because parasympathetic activation dilates blood vessels and relaxes the mind and body. - Translation:
Within just 2 hours, AMO+ shifted the body from “Fight or Flight” mode into a calmer, relaxed “Rest & Digest” state. This helps the body unwind, improves relaxation, and prepares for better sleep. - Scientific:
However, there was no significant difference in HF ratio on ECG after use of the placebo product for a short term (2 hours) - Translation:
The fake test device (placebo) did NOT create any relaxation effect — only AMO+ produced measurable results. - Scientific:
There were significant changes in HF ratio on ECG for a long term (72 hours) after use of AMO+. This demonstrated that AMO+ not only has short term effects, but also provides long term effects, activating the parasympathetic nervous system. - Translation:
AMO+ significantly changed the HF ratio on ECG, and its benefits were shown to last well beyond an immediate effect — remaining effective for at least 72 hours. This demonstrates both short-term and long-term benefits of the device. - Scientific:
The effect of activating the parasympathetic nervous system of AMO+ is considered effective for sympathetic hyperactivity (immune depression, increased fatigue, insomnia, etc.) suffered by many modern people due to heavy work load and stress. - Translation:
AMO+ helps reduce chronic stress by calming an overactive stress response (“sympathetic dominance”), leading to better emotional balance and relaxation.
2nd Clinical Trial: 48% Reduction in Insomnia Severity
Kyung Hee University Hospital
In a clinical trial conducted at Kyung Hee University Hospital in 2019, the sleep improvement effect was demonstratedthrough analysis on Insomnia Severity Index (ISI).
We conducted a 30-day study with adults who self-reported sleep difficulties and after using AMO+, we found that:
- 95% of participants improved their overall Sleep Score; 85% were more satisfied with their sleep pattern.
- 75% reported positive impact on their daily functioning.
- A statistically significant reduction in mean Insomnia Severity Index (ISI) score from 15.7 (moderate insomnia) at baseline to 8.15 (sub-threshold insomnia) after 14 days of cVES treatment was observed.
- ISI score reduced by 7.55 (i.e., 48% reduction).
3rd Clinical Trial: Proving Sleep Improvement
KRISS (Korea Research Institute of Standards and Science)
In a clinical trial conducted at the KRISS (Korea Research Institute of Standards and Science) in 2020, EEG (electroencephalogram), ECG (electrocardiogram) and melatonin (sleep-inducing hormone) were analyzed to demonstrate the effectiveness on the activation of parasympathetic nervous system of the ANS (autonomic nervous system) and the improvement in sleep, stress, and brain function.
Conclusion
The HF ratio increased in both normal individuals and insomnia patients, indicating stress reduction.
In the electroencephalogram (EEG) analysis, the increase of alpha wave ratios in F3, F4, Fp1, and Fp2 positions in insomnia patients after wearing real devices indicates stress reduction. In the saliva test, the increase in melatonin levels in insomnia patients at nighttime indicates an increase in sleep-inducing effects. In conclusion the real AMO+ devices reduce stress and improve sleep induction.
